The Senior Vice President, Clinical Development is responsible for providing strategic leadership for the clinical/medical aspects of all phases of drug development across all therapeutic areas, compounds and/or indications. The incumbent is accountable for ensuring that clinical trials and protocols are properly designed and executed in accordance with applicable Good Clinical Practice (GCP) regulations. He/she is also accountable for defining and leading the strategic design of programs/studies such that there is strategic alignment across the portfolio. The role provides oversight for the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical and regulatory objectives, and the documentation of study results. This includes, but may not be limited to, overseeing the activities of the Clinical organization.
The incumbent is a key representative of PTC’s clinical development organization in meetings with external stakeholders and audiences as needed; he/she may also author, or review for scientific/ medical purposes, clinical/medical-related materials intended for internal and/or external audiences.
He/she manages direct and indirect reports.
The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.
The Senior Vice President, Clinical Development is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.